Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
AMITRAZ (UNII: 33IAH5017S) (AMITRAZ - UNII:33IAH5017S)
Zoetis Inc.
amitraz
amitraz 0.18 g in 1 mL
TOPICAL
PRESCRIPTION
MITABAN (amitraz) is indicated for treatment of generalized demodicosis (Demodex canis) in dogs. Current data do not support use for treatment of localized demodicosis or scabies. - Fertility impairment studies have not been conducted in the canine with MITABAN (amitraz). It is not known whether MITABAN may cause impairment of fertility in dogs. - Reproduction studies during pregnancy have not been conducted with MITABAN. It is not known whether MITABAN may harm the embryo or fetus. - The safety of MITABAN has not been established for dogs less than four months of age.
MITABAN Liquid Concentrate (amitraz) is available in cartons of 6–10.6 mL bottles.
New Animal Drug Application
MITABAN- AMITRAZ LIQUID ZOETIS INC. ---------- MITABAN AMITRAZ Liquid Concentrate FOR TOPICAL USE ON DOGS FOR USE IN ANIMALS ONLY CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. WARNING Animal safety studies conducted in the dog and other species suggest amitraz may alter the animal's ability to maintain homeostasis. Animals treated with MITABAN (amitraz) should not be subjected to stress for a period of at least 24 hours posttreatment. Adverse reactions including three fatalities were reported during the clinical studies. In excess of 1100 dogs with generalized demodicosis were topically treated with MITABAN. DESCRIPTION MITABAN (amitraz) Liquid Concentrate contains 19.9% N'-(2,4 dimethylphenyl)-N-[[(2,4- dimethylphenyl)imino]methyl]-N-methylmethanimidamide (w/w), and also xylol, propylene oxide, and a blend of alkyl benzene sulfonates and exthoxylated polyethers. Amitraz, a diamide, is pale yellow, has a melting point of 86° to 87° C, is not hygroscopic, is stable to heating, soluble in most organic solvents, and sparingly soluble in water. CLINICAL PHARMACOLOGY Amitraz is hydrolyzed to 2,4-dimethyl-formanilide and N-(2,4-dimethylphenyl)-N'-methylformamidine; these metabolites are further metabolized to 2,4-dimethylaniline and ultimately to 4-amino-3- methylbenzoic acid, which was the principal metabolite in the urine and liver. Radiolabeled amitraz was administered to beagles as a single oral treatment at a level of 4 mg/kg. Peak blood levels were reached between 1.5 and 6 hours posttreatment; the half-life was approximately 12 hours during the initial 48 hours. Radioactivity was extremely low in whole blood and plasma at 72 (0.05-0.06 ppm) and 96 (0.03- 0.06 ppm) hours. The organs having residues at levels greater than plasma concentrations at 96 hours included: liver, skin, eyes, bile, kidney, medulla, cerebrum, lungs, gonads, fat, thyroid, spleen, and large intestine. The main metabolite isolated from these tissues was identified as 4-amino-3-methylbenz Izlasiet visu dokumentu